NCT06749132Enrolling By Invitation不适用
Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Annualized change in AV Vmax in m/sec/years
研究概览
简要总结
This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS
排除标准
- •Opted out of research studies
- •Non-English speaking
- •Any echocardiogram within 24 months of medical record review.
- •Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
- •Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
- •Prior heart transplant
- •History of dementia
- •Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
- •Documented life expectancy of <1 year or current participation in hospice services
结局指标
主要结局
Annualized change in AV Vmax in m/sec/years
时间窗: From baseline TTE to TTE performed at enrollment
The primary outcome measure is the annualized change in AV Vmax in m/sec/years, defined as the absolute difference between the value on the enrollment and baseline echocardiogram measurement, divided by the time difference between the studies.
次要结局
未报告次要终点
研究者
研究点 (4)
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